Active substance: Escherichia coli, Staphylococcus aureus

Territory / Distribution category: NI POM-V

Authorisation holder: Boehringer Ingelheim Vetmedica GmbH

Link to SPC

Active substance: Cefalexin

Territory / Distribution category: GB POM-V

Authorisation holder: Emdoka bvba

Link to SPC

Active substance: Pergolide mesylate

Territory / Distribution category: NI POM-V

Authorisation holder: Alfasan Nederland B.V.

Link to SPC

Active substance: Carprofen

Territory / Distribution category: NI POM-V

Authorisation holder: Alfasan Nederland B.V.

Link to SPC 8mg

Link to SPC 20mg

Link to SPC 40mg

Link to SPC 80mg

Active substance: Carprofen

Territory / Distribution category: NI POM-V

Authorisation holder: Alfasan Nederland B.V.

Link to SPC 20mg

Link to SPC 50mg

Link to SPC 100mg

Active substance: Meloxicam

Territory / Distribution category: GB & NI POM-V

Authorisation holder: C&H Generics Ltd

Link to GB SPC

Link to NI SPC

Active substance: Dexmedetomidine Hydrochloride

Territory / Distribution category: NI POM-V

Authorisation holder: Accord Healthcare B.V

Link to NI SPC

Active substance: Meloxicam

Territory / Distribution category: GB & NI POM-V

Authorisation holder: C&H Generics Ltd

Link to GB SPC

Link to NI SPC

Active substance: Prednisolone

Territory / Distribution category: NI POM-V

Authorisation holder: Accord Healthcare B.V

Link to SPC 1mg

Link to SPC 5mg

Link to SPC 25mg

Active substance: Meloxicam

Territory / Distribution category: GB POM-V

Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd

Link to SPC

Active substance: Robenacoxib

Territory / Distribution category: GB POM-V

Authorisation holder: KRKA, d.d., Novo mesto

Link to SPC

Active substance: Molidustat sodium

Territory / Distribution category: GB POM-V

Authorisation holder: Elanco GmbH

Link to SPC

Active substance: Amoxicillin

Territory / Distribution category: UK POM-V

Authorisation holder: Norbrook Laboratories Limited

Change Category: Adverse reactions

Summary of change:  

Section 4.6: Penicillins and cephalosporins may cause hypersensitivity (allergy, allergic skin reactions) after use. Allergic reactions may occasionally be serious (anaphylaxis).

Link to SPC

Active substance: Florfenicol

Territory / Distribution category: GB & NI POM-V

Authorisation holder: Norbrook Laboratories Limited

Change Category: Environmental impact

Summary of change:  

Section 6.6: The veterinary medicinal product should not enter water courses as florfenicol may be dangerous for fish and other aquatic organisms.

Link to GB SPC

Link to NI SPC

Active substance: Lotilaner

Territory / Distribution category: GB NFA-VPS

Authorisation holder: Elanco GmbH

Change Category: Adverse reactions

Summary of change:  

Section 4.6: Additions of bloody diarrhoea, polydipsia, pruritus (itching), inappropriate urination, polyuria (increased urination), and urinary incontinence at a frequency of “very rare” (<1 animal / 10,000 animals treated, including isolated reports).

Link to SPC 56mg

Link to SPC 112mg

Link to SPC 225mg

Link to SPC 450mg

Link to SPC 900mg

Active substance: Lotilaner

Territory / Distribution category: NI POM-V

Authorisation holder: Elanco GmbH

Change Category: Target species use

Summary of change:  

Section 3.2: Addition of two new indications:

For the treatment of sarcoptic mange (Sarcoptes Scabiei).

By killing the vector Dermacentor reticulatus, the veterinary medicinal product reduces the risk of transmission of the vector-borne pathogen Babesia canis canis.

SPCs available from EU Union Product Database

Active substance:  Lotilaner

Territory / Distribution category: NI POM-V

Authorisation holder: Elanco GmbH

Change Category: Target species use

Summary of change:  

Section 3.2: Addition of two new indications:

For the treatment of sarcoptic mange (Sarcoptes Scabiei).

By killing the vector Dermacentor reticulatus, the veterinary medicinal product reduces the risk of transmission of the vector-borne pathogen Babesia canis canis.

SPCs available on the EU Union Product Database

Active substance: Emodepside, Praziquantel,

Tigolaner

Territory / Distribution category: GB & NI POM-V

Authorisation holder: Vetoquinol SA

Change Category: Adverse reactions

Summary of change:  

Section 3.6: Addition of Application site reaction (e.g. scratching, erythema, hair loss, inflammation) (mild and transient) at a frequency of “rare” (more than 1 but less than 10 animals in 10,000 animals treated).

Link to GB SPC 1 - 2.5kg

Link to GB SPC >2.5 - 5kg

Link to GB SPC >5 - 8kg

NI SPCs available from EU Union Product Database

Active substance: Cabergoline

Territory / Distribution catgory: UK POM-V

Authorisation holder: Ceva Salute Animale S.p.A

Change Category: Adverse events

Summary of change:  

Section 3.6: Updated: anorexia at a frequency of “very common” (more than 1 in 10 animals treated displaying adverse event(s)), vomiting at a frequency of “common”(more than 1 but less than 10 animals in 100 animals treated), and drowsiness, muscle tremor, ataxia, twitching, trembling, hyperactivity, restlessness, aggression, distress, hyperexcitation, hypotension, and allergic reaction at a frequency of “very rare” (<1 animal / 10,000 animals treated, including isolated reports).

Link to SPC

Active substance: Bedinvetmab

Territory / Distribution catgory: NI POM-V

Authorisation holder: Zoetis Belgium

Change Category: Adverse events

Summary of change:  

Section 4.6: Updated: diarrhoea and vomiting at a frequency of “rare” (more than 1 but less than 10 animals in 10,000 animals treated) and low amounts of red blood cells (immune- mediated haemolytic anaemia), joint pain, lameness and swelling in multiple joints (immune-mediated polyarthritis), low amounts of platelets (thrombocytes) (immune-mediated thrombocytopenia), weakness, loss of movement, and convulsion at a frequency of “very rare” (<1 animal / 10,000 animals treated, including isolated reports).

SPCs available from EU Union Product Database

Active substance: Lotilaner

Territory / Distribution category: NI POM-V

Authorisation holder: Elanco GmbH

Change Category: Target species use

Summary of change:

Section 3.2: Addition of two new indications:

For the treatment of sarcoptic mange (Sarcoptes Scabiei).

By killing the vector Dermacentor reticulatus, the veterinary medicinal product reduces the risk of transmission of the vector-borne pathogen Babesia canis canis.

SPCs available from EU Union Product Database

Active substance: Meloxicam

Territory / Distribution category: NI POM-V

Authorisation holder: CP Pharma Handelsgesellschaft mbH

Change Category: Target species use

Summary of change:

Section 4.2: Addition of alleviation of pain and inflammation in acute musculo-skeletal disorders in cats.

SPC available from EU Union Product Database

Active substance:  Afoxolaner

Territory / Distribution category: GB POM-V

Authorisation holder: Boehringer Ingelheim Vetmedica Gmbh

Change Category: Target species use

Summary of change:

Section 3.2 Addition of two new indications: 

For reduction of the risk of infection with Babesia canis via transmission by Dermacentor reticulatus for 28 days. The effect is indirect due to the activity of the veterinary medicinal product against the vector. 

For reduction of the risk of infection with Dipylidium caninum via transmission by Ctenocephalides felis for 30 days. The effect is indirect due to the activity of the veterinary medicinal product against the vector.

Link to SPC 11mg

Link to SPC 28mg

Link to SPC 68mg

Link to SPC 136mg

Active substance:  Leptospira australis,

Leptospira canicola, Leptospira grippotyphosa, Leptospira icterohaemorrhagiae

Territory / Distribution category: GB POM-V

Authorisation holder: MSD Animal Health UK Limited 

Change Category: Target species use; Adverse events; Interactions and Overdose

Summary of change:

Section 3.2: Addition of new indications:

Indications against two new Leptospira serovars - Icterohaemorrhagiae and Grippotyphosa

Indications against existing Leptospira serovars Canicola, Copenhageni, Bananal/Liangguang, and Bratislava and efficacy against serovar Australis. 

Section 3.6: Addition of injection site swelling up to 6.5 cm on the day of vaccination and elevated temperature ≤ 1.4 °C, up to 3 days after vaccination at a frequency of “very common” (more than 1 in 10 animals treated displaying adverse event(s)).

Section 3.8: Addition of a new associated non-mixed use claim with Nobivac Rabies.

Link to SPC

Active substance: Emodepside, Praziquantel

Territory / Distribution category: GB & NI NFA-VPS

Authorisation holder: KRKA, d.d., Novo mesto

Active substance: Emodepside, Praziquantel

Territory / Distribution category: GB & NI NFA-VPS

Authorisation holder: KRKA, d.d., Novo mesto

Active substance: Emodepside, Praziquantel

Territory / Distribution category: GB & NI NFA-VPS

Authorisation holder: KRKA, d.d., Novo mesto

Active substance: Emodepside, Praziquantel

Territory / Distribution category: GB & NI NFA-VPS

Authorisation holder: KRKA, d.d., Novo mesto

Active substance: Lincomycin

Territory / Distribution category: GB & NI, POM-V

Authorisation holder: Endectovet EOOD

Link to GB SPC

Link to NI SPC

Active substance: Emodepside, Praziquantel

Territory / Distribution category: GB & NI NFA-VPS

Authorisation holder: KRKA, d.d., Novo mesto

Change Category: Target Species Use; Overdose and Interactions

Summary of change:  

Section 3.2: The indication for the treatment of lungworm infections has been removed.  

Section 3.8: Wording has been added recommending that veterinary advice should be sought before treatment if a cat is receiving other medications, and to inform the vet that this product is being used if other medication is provided. 

Section 3.9: Additional text has been included stating that the need for, and frequency of, re-treatments should be based on professional advice and should take into account individual risk factors (the local epidemiological situation and the animal’s lifestyle).

Link to GB SPC small cats

Link to NI SPC small cats

Link to GB SPC medium cats

Link to NI SPC medium cats

Link to GB SPC large cats

Link to NI SPC large cats

Active substance: Emodepside, Praziquantel

Territory / Distribution category: GB & NI NFA-VPS

Authorisation holder: KRKA, d.d., Novo mesto

Change Category: Target Species Use; Overdose and Interactions

Summary of change:  

Section 3.2: The indication for the treatment of lungworm infections has been removed.  

Section 3.8: Wording has been added recommending that veterinary advice should be sought before treatment if a cat is receiving other medications, and to inform the vet that this product is being used if other medication is provided. 

Section 3.9: Additional text has been included stating that the need for, and frequency of, re-treatments should be based on professional advice and should take into account individual risk factors (the local epidemiological situation and the animal’s lifestyle).

Link to GB SPC small cats

Link to NI SPC small cats

Link to GB SPC medium cats

Link to NI SPC medium cats

Link to GB SPC large cats

Link to NI SPC large cats

Active substance: Emodepside, Praziquantel

Territory / Distribution category: GB & NI NFA-VPS

Authorisation holder: KRKA, d.d., Novo mesto

Change Category: Target Species Use; Overdose and Interactions

Summary of change:  

Section 3.2: The indication for the treatment of lungworm infections has been removed.  

Section 3.8: Wording has been added recommending that veterinary advice should be sought before treatment if a cat is receiving other medications, and to inform the vet that this product is being used if other medication is provided. 

Section 3.9: Additional text has been included stating that the need for, and frequency of, re-treatments should be based on professional advice and should take into account individual risk factors (the local epidemiological situation and the animal’s lifestyle).

Link to GB SPC small cats

Link to NI SPC small cats

Link to GB SPC medium cats

Link to NI SPC medium cats

Link to GB SPC large cats

Link to NI SPC large cats

Active substance: Emodepside, Praziquantel

Territory / Distribution category: GB & NI NFA-VPS

Authorisation holder: KRKA, d.d., Novo mesto

Change Category: Target Species Use; Overdose and Interactions

Summary of change:  

Section 3.2: The indication for the treatment of lungworm infections has been removed.  

Section 3.8: Wording has been added recommending that veterinary advice should be sought before treatment if a cat is receiving other medications, and to inform the vet that this product is being used if other medication is provided. 

Section 3.9: Additional text has been included stating that the need for, and frequency of, re-treatments should be based on professional advice and should take into account individual risk factors (the local epidemiological situation and the animal’s lifestyle).

Link to GB SPC small cats

Link to NI SPC 30mg

Link to GB SPC 60mg

Link to NI SPC 60mg

Link to GB SPC 96mg

Link to NI SPC 96mg

Active substance: Moxidectin, Pyrantel, Sarolaner

Territory / Distribution catgory: GB POM-V

Authorisation holder: Zoetis UK Limited

Change Category: Target Species Use

Summary of change:  

Section 3.2: Addition of two new indications: 

- The treatment of Angiostrongylus vasorum, along with associated dosing information and precautions.

- Reduction in the risk of Dipylidium caninum via transmission by Ctenocephalides felis.

Link to SPC 1.25 - 2.5kg

Link to SPC >2.5kg - 5kg

Link to SPC >5 - 10kg

Link to SPC >10 - 20kg

Link to SPC >20 - 40kg

Link to SPC >40 - 60kg

Active substance: Febantel, Praziquantel, Pyrantel

Territory / Distribution catgory: NI NFA-VPS

Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd

Change Category: Adverse events

Summary of change:  

Section 3.6 of the SPC: Updated to include of adverse events: lethargy, anorexia, and hyperactivity at a frequency of very rare (<1 animal/10,000 animals treated, including isolated reports).

Link to SPC

Active substance:  

Febantel

Praziquantel

Pyrantel Embonate

Territory / Distribution category: NI NFA-VPS

Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd

Change Category: Adverse events

Summary of change:

Section 3.6 of the SPC: Updated to include adverse events lethargy, anorexia and hyperactivity at a frequency of very rare (<1 animal/ 10,000 animals treated, including isolated reports). 

Link to SPC

Active substance: Recombinant RHDV2 virus capsid protein

Territory / Distribution category: GB & NI POM-V

Authorisation holder: Laboratorios Hipra SA

Change Category: Adverse events

Summary of change:  

Section 3.6 of the SPC: Updated to include adverse events anorexia and intestinal stasis at a frequency of very rare (<1 animal/ 10,000 animals treated, including isolated reports). 

Link to GB SPC 

NI SPC available from the EU Union Product Database

Active substance: Febantel, Praziquantel,

Pyrantel Embonate

Territory / Distribution category: GB AVM-GSL

Authorisation holder: Vetoquinol UK Limited

Link to SPC

Active substance: Praziquantel, Pyrantel Embonate

Territory / Distribution category: UK AVM-GSL

Authorisation holder: Vetoquinol UK Limited

Link to SPC

Active substance: Neomycin sulphate

Territory / Distribution category: NI POM-V

Authorisation holder: Huvepharma NV

Link to SPC

Active substance: Mycoplasma hyopneumoniae, Porcine circovirus-2

Territory / Distribution category: GB POM-V

Authorisation holder: MSD Animal Health UK Limited

Link to SPC

Active substance: Amoxicillin

Territory / Distribution category: GB & NI POM-V

Authorisation holder: Univet Limited

Link to GB SPC

Link to NI SPC

Active substance: Bexagliflozin

Territory / Distribution category: GB POM-V

Authorisation holder: Elanco GmbH

Link to SPC

Active substance: Milbemycin oxime (A3 and A4), Praziquantel

Territory / Distribution category: GB & NI POM-V

Authorisation holder: C&H Generics Ltd

Link to GB SPC

Link to NI SPC

Active substance: Praziquantel, Milbemycin oxime (A3 and A4)

Territory / Distribution category: GB & NI POM-V

Authorisation holder: C&H Generics Ltd

Link to GB SPC

Link to NI SPC

Active substance: Praziquantel, Milbemycin oxime (A3 and A4)

Territory / Distribution category: GB & NI POM-V

Authorisation holder: C&H Generics Ltd

Link to GB SPC

Link to NI SPC

Active substance: Ketamine

Territory / Distribution category: GB  & NI POM-V

Authorisation holder: Eurovet Animal Health B.V

Change Category: Safety warnings

Summary of change:  

Section 4.9 of the SPC: The vials are not vacuum-sealed and do not require air to be introduced to withdraw its content.

Introducing air into the vial prior to withdrawal of its content may lead to leakage.

Link to GB SPC 

Link to NI SPC

Active substance: Salmonella typhimurium

Territory / Distribution category: GB POM-V

Authorisation holder: Elanco Europe Ltd

Change Category: Target species use; Contraindications, Special warnings 

Summary of change:  

Section 3.2 of SPC: The duration of immunity for breeders and layers has been updated to 46 weeks from the time of the last vaccination.

Section 3.4: In the presence of maternally derived antibodies, a single minimum dose of vaccine administered at one day of age protects against systemic infection with Salmonella Typhimurium field strain, but no information on shedding is available. Not tested on ornamental and pure-bred poultry.

Section 3.5: The vaccine strain can also be distinguished from field strains by molecular biology methods, such as a real-time polymerase chain reaction (PCR) method.

Link to SPC

Active substance: Bluetongue virus

Territory / Distribution catgory: NI POM-V

Authorisation holder: CZ Vaccines S.A.U.

Change Category: Target species use

Summary of change:  

Section 3.9 of SPC: The posology for bivalent vaccines containing bluetongue virus (BTV) serotypes 1 and 4 has been updated for sheep. The following revised guidance now applies. ‘For monovalent vaccines containing bluetongue virus serotype 1 or serotype 4 administer one dose of 2 ml subcutaneously. For bivalent vaccines containing bluetongue virus serotype 1 and serotype 4 administer one dose of 2 ml subcutaneously.’

SPC available from the EU Union Product Database 

Active substance: 

Territory / Distribution catgory: NI POM-V

Authorisation holder: Laboratorios Hipra SA

Change Category: Adverse reactions; Safety warnings

Summary of change:  

Section 3.6 of the SPC: Updated to include adverse events related to a temporary mild reduction in milk production, feed intake and activity as uncommon (1 to 10 animals/10,000 animals treated).

Section 3.9 of SPC: To clarify that the vaccine should be used at a temperature between 15 °C and 25 °C prior to administration.

SPC available from the EU Union Product Database 

Active substance: Florfenicol

Territory / Distribution category: GB POM-V

Authorisation holder: Emdoka

Change Category: Contraindications and special warnings

Summary of change:

Section 5.5 of the SPC: The veterinary medicinal product should not enter water courses as florfenicol may be dangerous for fish and other aquatic organisms.

Link to SPC

Active substance: Closantel

Territory / Distribution category: NI POM-VPS

Authorisation holder: Norbrook Laboratories Limited

Change Category: Withdrawal period

Summary of change:  

Section 4.11 of the SPC: Withdrawal period for meat and offal 56 days.

Link to SPC 

Active substance: Closantel

Territory / Distribution category: GB & NI POM-V

Authorisation holder: Eurovet Animal Health B.V 

Change Category: Safety warnings

Summary of change:  

Section 4.9 of the SPC: The vials are not vacuum-sealed and do not require air to be introduced to withdraw its content.

Introducing air into the vial prior to withdrawal of its content may lead to leakage.

Link to GB SPC

Link to NI SPC

Active substance: Fluralaner, Moxidectin, Pyrantel

Territory / Distribution category: NI POM-V

Authorisation holder: Intervet International B.V.

Change Category: Target species use

Summary of change:  

Addition of treatment claim for Angiostrongylus vasorum (the causative agent of angiostrongylosis). 

SPCs available from EU Union Product Database

Active substance: Febantel, Praziquantel, Pyrantel Embonate

Territory / Distribution category: NI NFA-VPS

Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd

Change Category: Adverse reactions

Summary of change:  

Section 4.6 of the SPC: Updated to include adverse events lethargy, anorexia and hyperactivity at a frequency of very rare (<1 animal/ 10,000 animals treated, including isolated reports).

Link to SPC

Active substance: Emodepside, Praziquantel

Territory / Distribution category: GB NFA-VPS

Authorisation holder: Vetoquinol UK Limited

Change Category: Name change

Summary of change:  

The name change to 'Drontal wormer'

Link to SPC 30mg

Link to SPC 60mg

Link to SPC 96mg

Active substance: Febantel, Praziquantel, 

Pyrantel Embonate

Territory / Distribution category: GB AVM-GSL

Authorisation holder: Vetoquinol UK Limited

Change Category:

Summary of change:  

Name change to 'Johnson’s Wormer Plus 150/144/50 mg Tablets for Dogs & Puppies' 

Link to SPC

Active substance: Capromorelin tartrate

Territory / Distribution category: GB POM-V

Authorisation holder: Elanco GmbH

Change Category: Adverse reactions

Summary of change:  

Section 3.6 of the SPC: Updated to include adverse events anorexia and behavioural disorder (rare frequency) and loss of consciousness, sedation, recumbency and dyspnoea (very rare frequency).

Link to SPC

Active substance: Febantel, Praziquantel, Pyrantel

Territory / Distribution category NI NFA-VPS

Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd

Change Category: Adverse reactions

Summary of change:  

Section 3.6 of the SPC: Updated to include lethargy, anorexia and hyperactivity as very rare (<1 animal /10,000 animals treated, including isolated reports).

Link to SPC

Active substance: Imidacloprid

Territory / Distribution category: AVM-GSL

Authorisation holder: Elanco Europe Ltd

Link to SPC 40mg

Link to SPC 80mg

Active substance: Febantel, Pyrantel

Territory / Distribution category: GB AVM-GSL

Authorisation holder: Vetoquinol UK Limited

Section 3.3: Do not use simultaneously with compounds containing piperazine as piperazine may block the action of pyrantel embonate contained in the product. Other worming products may contain piperazine. 

Do not use simultaneously with other worming products without veterinary advice. 

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not use during pregnancy.

Do not use in lactating bitches.

Link to SPC 15mg/ml

Link to SPC 5mg/ml

Active substance: Equine influenza virus

Territory / Distribution category: GB POM-V

Authorisation holder: Bioveta, a.s.

Link to SPC

Active substance: Equine influenza virus, Clostridium tetani

Territory / Distribution category: GB POM-V

Authorisation holder: Bioveta, a.s.

Link to SPC

Active substance: Diclazuril

Territory / Distribution category: GB & NI POM-VPS

Authorisation holder: Huvepharma NV

Link to GB SPC

Link to NI SPC

Active substance: Xylazine

Territory / Distribution category: GB POM-V

Authorisation holder: VetViva Richter GmbH

Link to SPC

Active substance: Betamethasone acetate, Terbinafine

Territory / Distribution category: GB POM-V

Authorisation holder: Dechra Regulatory B.V.

Link to SPC

Active substance: Robenacoxib

Territory / Distribution category: GB & NI POM-V

Authorisation holder: KRKA, d.d., Novo mesto

Link to GB SPC

Link to NI SPC

Active substance: Salmonella enteritidis

Territory / Distribution category: UK POM-V

Authorisation holder: Elanco Europe Ltd

Change Category: Contraindications; Special warnings

Summary of change:  

Section 3.5: Addition of a real time PCR method to differentiate the Salmonella vaccine strain from wild-type field isolates as an additional DIVA method.

Link to SPC 

Active substance: Salmonella typhimurium

Territory / Distribution category: NI POM-V

Authorisation holder: Elanco Europe Ltd

Change Category: Target species use; contraindications, special warnings

Summary of change:  

Section 3.2: Amendment of the duration of immunity for breeders and layers to 46 weeks.

Section 3.5: Addition of a real time PCR method to differentiate the Salmonella vaccine strain from wild-type field isolates as an additional DIVA method.

Link to SPC

Active substance: Cloprostenol

Territory / Distribution catgory: NI, POM-V

Authorisation holder: Vetoquinol UK Ltd

Change Category: Contraindications, Special warnings

Summary of change:  

Section 3.3: Do not use in cases of bronchospasm or gastrointestinal dysmotility.

Section 3.4: The response of sows and gilts to induction of parturition may be influenced by the physiological state at the time of treatment. The vast majority of the animals, 95%, will commence farrowing within 36 hours of treatment. The majority of animals can be expected to respond within the period of 24+/- 5 hours following the injection, except in those cases where spontaneous parturition is imminent.

Section 3.5: To reduce the risk of anaerobic infections arising from vasoconstriction at the injection site, injections into contaminated (wet or dirty) skin areas should be avoided. Thoroughly clean and disinfect injection sites prior to administration.

Injection into adipose tissue may lead to incomplete absorption of the veterinary medicinal product. 

Premature induction of farrowing will reduce the piglet`s birth weight and increase the number of stillborn piglets and non-viable and immature born piglets. It is essential that the mean length of gestation is calculated on each farm from past records and not to anticipate the term of gestation by more than two days.

Do not administer intravenously.

Section 3.7: Pregnancy: Do not administer to pregnant animals unless the objective is to terminate the pregnancy. 

Fertility: There is no effect on the subsequent reproductive performance of sows treated with cloprostenol and of gilts or boars born from treated animals.

Section 3.8: In animals to which a progestogen is being administered, a decrease in the response of cloprostenol can be expected.

Link to SPC

Active substance: Flunixin

Territory / Distribution catgory: GB POM-V

Authorisation holder: Global Vet Health S.L.

Change Category: Target species use; Contraindications, Special warnings

Summary of change:  

Section 3.2 Indications updated:

Cattle

Adjunctive therapy in the treatment of bovine respiratory diseases, endotoxemia and acute mastitis.

Alleviation of acute inflammation and pain associated with musculoskeletal disorders.

Reduction of post-operative pain associated with dehorning in calves of less than 9 weeks.

Horses

Alleviation of acute inflammation and pain associated with musculoskeletal disorders.

Alleviation of visceral pain associated with colic.

Adjunctive therapy of endotoxemia due to or as a result of post-surgical or medical conditions or diseases that result in impaired blood circulation in the gastrointestinal tract. 

Reduction of pyrexia.

Pigs

Adjunctive therapy in the treatment of swine respiratory disease. 

Adjunctive treatment of postpartum dysgalactia (Mastitis-Metritis-Agalactia) syndrome in sows.

Alleviation of acute inflammation and pain associated with musculoskeletal disorders.

Reduction of post-operative pain following castration and tail docking in sucking piglets.

Section 3.3: Do not use if haematopoiesis or haemostasis is impaired.

Section 3.7: 

Pregnancy: The safety of the veterinary medicinal product has been established in pregnant cows and sows. Do not use the veterinary medicinal product within 48 hours before expected parturition in cows and sows.

The safety of the veterinary medicinal product has not been established in pregnant mares. Do not use during the whole of the pregnancy.

Laboratory studies in rats have revealed fetotoxicity of flunixin after intramuscular administration at maternotoxic doses as well as an extension of the gestation period.  

The veterinary medicinal product must be used within the first 36 hours postpartum only following a benefit/risk assessment performed by the responsible veterinarian and treated animals should be monitored for retained placenta.

Fertility: The safety of the veterinary medicinal product has not been established in bulls, stallions and boars intended for breeding. Do not use in breeding bulls, breeding stallions and breeding boars.

Section 3.12: Withdrawal periods changed:

Cattle

Meat and offal: 4 days (intravenous use)

31 days (intramuscular use)

Milk: 24 hours (intravenous use)

36 hours (intramuscular use)

Pigs

Meat and offal: 24 days (intramuscular use)

Horses

Meat and offal: 5 days (intravenous use)

Milk: Not authorised for use in animals producing milk for human consumption

Further extensive updates to sections 3.5 (target species and user safety warnings), 3.6 (Adverse events), 3.9 (Administration routes and dosage) and 3.10 (Symptoms of overdose). Refer to product SPC for details.

Link to SPC

Active substance: Pentobarbital Sodium

Territory / Distribution category: GB & NI POM-V

Authorisation holder: Alfasan Nederland B.V. 

Change Category: Target species use

Summary of change:

Addition of new target species and associated dosing information.

Original target species: pigs, goats, sheep, cattle, horses, cats and dogs

Additional new target species: rabbits, guinea pigs, mice, rats, hamsters, chickens, pigeons, ducks, small ornamental birds, snakes, turtles, lizards and frogs.

Link to GB SPC 20%

Link to NI SPC 20%

Link to GB SPC 40%

Link to NI SPC 40%

Active substance: Amoxicillin

Territory / Distribution category: NI POM-V

Authorisation holder: V.M.D. n.v.

Change Category: Indications

Summary of change:  

New indication in pigs: For the treatment of infections caused by Streptococcus suis.

Link to SPC 

Active substance: Pergolide

Territory / Distribution category: GB & NI POM-V

Authorisation holder: VetViva Richter GmbH

Change Category: Contraindications, special warnings

Summary of change:  

Section 3.5: Extensive changes to user safety warnings. Refer to product SPC for details.

Link to GB SPC 

Link to NI SPC

Active substance: Moxidectin

Territory / Distribution category: GB & NI POM-VPS

Authorisation holder: Zoetis UK Limited

Change Category: Contraindications, Special warnings

Summary of change:  

Section 4.4: Resistance to moxidectin has been reported in Cooperia spp. and Ostertagia spp. in cattle. (100 mg/ml product only)

Psoroptes ovis is an extremely contagious external parasite of sheep and cattle. To ensure complete control, great care must be taken to avoid reinfestation, as mites may be viable for up to 15 days off the animal. It is important that all animals which have been in contact with infected ones are treated with an appropriate product. Contact between treated, infected and untreated herds must be avoided until at least seven days after treatment.

Resistance to moxidectin has been reported in Psoroptes ovis scab mites in sheep and in cattle. Cases of side-resistance with other macrocyclic lactones (ivermectin and doramectin) have been reported as well. The use of this product should take into account local information about susceptibility of the target parasites, where available.

Section 4.5: To prevent a possible anaphylactic type reaction, do not inject the product intravenously.’ (100 mg/ml product only)

Section 4.9 (Amounts to be administered and administration route) also updated, refer to SPC for details.

Link to GB SPC 100mg/ml Cattle

Link to NI SPC 100mg/ml Cattle

Link to GB SPC 20mg/ml Sheep

Link to NI SPC 20mg/ml Sheep

Active substance: Lotilaner

Territory / Distribution category: GB POM-V

Authorisation holder: Elanco GmBH

Change Category: Adverse reactions

Summary of change:  

Section 4.6: Addition of anorexia, lethargy, tachypnoea, ataxia, muscle tremor, hyperactivity and pruritus as adverse events with ‘very rare’ frequency (<1 animal / 10,000 animals treated, including isolated reports).

Link to SPC 12mg

Link to SPC 48mg

Active substance: Florfenicol; Mometasone Furoate; Terbinafine hydrochloride

Territory / Distribution category: GB POM-V

Authorisation holder: Elanco Animal Health GmbH

Change Category: Adverse Reactions

Summary of change:  

Section 4.6: Updated to include facial paralysis as very rare adverse reactions (<1 animal/10,000 animals treated, including isolated reports).  

Link to SPC

Active substance: Eprinomectin; Esafoxolaner; Praziquantel

Territory / Distribution category: GB POM-V

Authorisation holder: Boehringer Ingelheim Vetmedica GmbH

Change Category: Indications

Summary of change:  

Addition of new indication: Treatment of infections with eye worms (Thelazia callipaeda). 

Link to SPC <2.5kg

Link to SPC 2.5 - 7

Active substance: Moxidectin; Pyrantel; Sarolaner

Territory / Distribution category: GB POM-V

Authorisation holder: Zoetis UK Limited

Change Category: Target species use

Summary of change:  

Section 3.2: New indication for reduction of the risk of infection with Dipylidium caninum via transmission by Ctenocephalides felis for one month after treatment. The effect is indirect due to the product’s activity against the vector.

Link to SPC 1.25-2.5kg

Link to SPC >2.5-5kg

Link to SPC >5-10kg

Link to SPC >10-20kg

Link to SPC >20-40kg 

Link to SPC >40-60kg

Active substance: Sarolaner; Selamectin

Territory / Distribution category: GB & NI POM-V

Authorisation holder: Zoetis Belgium

Change Category: Target species use

Summary of change:  

Section 4.2: New indication for reduction of the risk of infection with Dipylidium caninum via transmission by Ctenocephalides felis for one month after treatment.  The effect is indirect due to the product’s activity against the vector.

Link to GB SPC

NI SPC available on EU Union Product Database

Active substance: Avian infectious bronchitis virus

Territory / Distribution category: GB POM-V

Authorisation holder: Genera d.d.

Link to SPC

Active substance: Salmonella enterica subsp. enterica

Territory / Distribution category: GB POM-V

Authorisation holder: Ceva Animal Health Ltd

Link to SPC

Active substance: Praziquantel

Territory / Distribution category: NI POM-V

Authorisation holder: Bioveta, a.s.

Link to SPC

Active substance: Azaperone

Territory / Distribution category: GB POM-V

Authorisation holder: CP Pharma Handelsgesellschaft mbH

Link to SPC

Active substance: Benazepril

Territory / Distribution category: GB POM-V

Authorisation holder: VIRBAC

Link to SPC

Active substance: Ilunocitinib

Territory / Distribution category: GB POM-V

Authorisation holder: Elanco GmbH

Link to SPC 4.8mg

Link to SPC 6.4mg

Link to SPC 8.5mg

Link to SPC 15mg

Active substance: Ilunocitinib

Territory / Distribution category: GB, POM-V

Authorisation holder: Elanco GmbH

Link to SPC 4.8mg

Link to SPC 6.4mg

Link to SPC 8.5mg

Link to SPC 15mg

Active substance: Imidacloprid; Flumethrin

Territory / Distribution category: GB NFA-VPS

Authorisation holder: VIRBAC

Link to SPC for Cats

Link to SPC for Dogs up to 8kg

Link to SPC for Dogs over 8kg

Active substance: Ilunocitinib

Territory / Distribution category: GB POM-V

Authorisation holder: Elanco GmbH

Link to SPC 4.8mg

Link to SPC 6.4mg

Link to SPC 8.5mg

Link to SPC 15mg

Active substance: Altrenogest

Territory / Distribution category: GB POM-V

Authorisation holder: Ceva Animal Health Ltd

Change Category: Target species use

Summary of change:  

Section 3.1 of the SPC updated from ‘weaned primiparous sows’ to ‘sows’.

Link to SPC 

Active substance: Furosemide

Territory / Distribution category: UK POM-V

Authorisation holder: Intervet International B.V.

Change Category: 

Summary of change:  

Section 3.6 of the SPC has been updated to include haemoconcentration, circulatory impairment, hypokalaemia and hyponatraemia as very rare adverse events (<1 animal/10,000 animals treated, including isolated reports).

For dogs, section 3.6 of the SPC has also been updated to include vomiting and staggering as very rare adverse events (<1 animal/10,000 animals treated, including isolated reports). 

Link to SPC

Active substance: Infectious bovine rhinotracheitis virus

Territory / Distribution catgory: GB POM-V

Authorisation holder: Laboratorios Hipra SA

Change category: 

Summary of change:  

Section 3.9 of the SPC updated to include a reference to the temperature (15 °C – 25 °C) of the vaccine before administration.

Link to SPC

Active substance: Eprinomectin

Territory / Distribution category: NI POM-VPS

Authorisation holder: Livisto Int'l, S.L.

Change Category: Target Species Use

Summary of change:  

Section 3.1 of the SPC updated to include two new target species (sheep and goats). It should also be noted that there are significant updates to sections 3.2, 3.3, 3.4 3.5, 3.6, 3.7, 3.9, 3.10, 3.12 and 4.3 of the SPC.

Link to SPC

Active substance: Fluralaner

Territory / Distribution category: GB POM-V

Authorisation holder: MSD Animal Health UK Limited

Change Category: Adverse events

Summary of change:  

Section 4.6 updated to include pruritus as a very rare adverse reaction (<1 animal/10,000 animals treated, including isolated reports).

Link to SPC 112.5mg

Link to SPC 250mg

Link to SPC 500mg

Link to SPC 1000mg

Link to SPC 1400mg

Active substance: Fluralaner

Territory / Distribution category: GB POM-V

Authorisation holder: MSD Animal Health UK Limited

Change Category: Adverse Reactions

Summary of change:  

Section 4.6 updated to include pruritus and ataxia as very rare adverse reactions (<1 animal/10,000 animals treated, including isolated reports).

Link to SPC 112.5mg

Link to SPC 250mg

Link to SPC 500mg

Active substance: Fluralaner

Territory / Distribution category: GB POM-V

Authorisation holder: MSD Animal Health UK Limited

Change Category: Adverse Reactions

Summary of change:  

Section 4.6 updated to include diarrhoea and pruritus as very rare adverse reactions (<1 animal/10,000 animals treated, including isolated reports).

Link to SPC 112.5mg

Link to SPC 250mg

Link to SPC 500mg

Link to SPC 1000mg

Link to SPC 1400mg

Active substance: Canine adenovirus, Canine distemper virus, Canine parainfluenza virus, Canine parvovirus

Territory / Distribution category: NI POM-V

Authorisation holder: Virbac

Change Category: Target species use; Contraindications, Special Warnings

Summary of change:  

Sections 3.4 and 3.9 of the SPC updated to include a possible vaccination of dogs from 6 weeks of age, when an early protection is recommended (in susceptible puppies).

Link to SPC

Active substance: Febantel, Praziquantel, Pyrantel

Territory / Distribution category: GB NFA-VPS

Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd

Change Category: Adverse events

Summary of change:  

Section 3.6 of the SPC updated to include lethargy, anorexia and hyperactivity as very rare adverse reactions. 

Link to SPC

Active substance: Emodepside, Praziquantel

Territory / Distribution category: NI NFA-VPS

Authorisation holder: Vetoquinol UK Limited

Change Category: Adverse events

Summary of change:  

Section 4.6 of the SPC has been updated to include diarrhoea as a very rare adverse reaction (<1 animal/10,000 animals treated, including isolated reports).  Additionally, the following statement has been added: ‘In very rare occasions, behavioural disorders, such as hyperactivity, anxiety and vocalisation may occur. Anorexia and lethargy have been reported in very rare occasions.

Link to SPC 30mg/7.5mg

Link to SPC 60mg/15mg

Link to SPC 96mg/24mg

Active substance: Febantel, Praziquantel, Pyrantel

Territory / Distribution category: GB NFA-VPS

Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd

Change Category: Adverse events

Summary of change:  

Section 4.6 of the SPC updated to include lethargy, anorexia and hyperactivity as very rare adverse reactions (<1 animal/10,000 animals treated, including isolated reports).

Link to SPC

Active substance: Capromorelin tartrate

Territory / Distribution category: NI POM-V

Authorisation holder: Elanco GmbH

Change Category: Adverse events

Summary of change:  

Section 3.6 of the SPC has been updated to include anorexia and behaviour disorders as rare adverse events and dyspnoea, loss of consciousness, sedation, recumbency, muscle weakness and hiding as very rare adverse events (<1 animal/10,000 animals treated, including isolated reports).

SPC available from EU Union Product Database

Active substance: Florfenicol, Mometasone Furoate, Terbinafine hydrochloride

Territory / Distribution category: NI POM-V

Authorisation holder: Elanco Animal Health GmbH

Change Category: Adverse Reactions

Summary of change:  

Section 3.6 of the SPC has been updated to include facial paralysis as a very rare adverse event.

SPC available from EU Union Product Database

Active substance: Afoxolaner

Territory / Distribution category: NI POM-V

Authorisation holder: Boehringer Ingelheim Vetmedica Gmbh

Change Category: Target Species use

Summary of change:  

Section 3.2 updated with the following information: ‘For reduction of the risk of infection with Babesia canis via transmission by Dermacentor reticulatus for 28 days.   For reduction of the risk of infection with Dipylidium caninum via transmission by Ctenocephalides felis for 30 days.  The effects are indirect due to the activity of the veterinary medicinal product against the vector’

SPCs available from Union Product Database

Active substance:  

Febantel

Praziquantel

Pyrantel Embonate

Territory / Distribution category: GB NFA-VPS

Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd

Change Category: Adverse Reactions

Summary of change:  

Section 4.6 of the SPC updated to include lethargy, anorexia and hyperactivity as very rare adverse reactions.

Link to SPC

Active substance: Emodepside, Praziquantel

Territory / Distribution category: NI NFA-VPS

Authorisation holder: Vetoquinol UK Limited

Change Category: Adverse events

Summary of change:  

Section 4.6 of the SPC has been updated to include diarrhoea as a very rare adverse reaction (<1 animal/10,000 animals treated, including isolated reports).  Additionally, the following statement has been added: ‘In very rare occasions, behavioural disorders, such as hyperactivity, anxiety and vocalisation may occur. Anorexia and lethargy have been reported in very rare occasions.’

SPCs available from Union Product Database

Active substance: Febantel, Praziquantel,

Pyrantel Embonate

Territory / Distribution category: GB NFA-VPS

Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd

Change Category: Adverse events

Summary of change:  

Section 4.6 of the SPC has been updated to include lethargy, anorexia and hyperactivity as very rare adverse reactions (<1 animal/10,000 animals treated, including isolated reports).

Link to SPC

Active substance: Equine influenza virus

Territory / Distribution category: NI  POM-V

Authorisation holder: Bioveta, a.s.

Link to SPC

Active substance: Clostridium tetani, Equine influenza virus

Territory / Distribution category: NI POM-V

Authorisation holder: Bioveta, a.s. Limited

Link to SPC

Active substance: Infectious bursal disease virus; Avian reovirus

Territory / Distribution category: NI POM-V

Authorisation holder: Intervet International B.V.

SPC Available from EU Union Product Database

Active substance: Newcastle disease virus, Infectious bursal disease virus, Avian reovirus, Egg drop syndrome virus

Territory / Distribution category: NI POM-V

Authorisation holder: Intervet International B.V.

SPC available on the EU Union Product Database

Active substance: Sulfadiazine, Trimethoprim

Territory / Distribution category: NI POM-V

Authorisation holder: CP Pharma Handelsgesellschaft mbH

Link to SPC

Active substance: Clenbuterol hydrochloride

Territory / Distribution category: NI POM-V

Authorisation holder: Alfasan Nederland B.V.

Link to SPC

Active substance: Chorionic Gonadotrophin

Territory / Distribution category: NI, POM-V

Authorisation holder: Laboratorios Calier, S.A.

Link to SPC

Active substance: Enflicoxib

Territory / Distribution category: GB, POM-V

Authorisation holder: Ecuphar NV

Link to SPC 140mg

Link to SPC 200mg

Active substance: Meloxicam

Territory / Distribution category: GB, POM-V

Authorisation holder: Accord Healthcare B.V

Link to SPC

Active substance: Meloxicam

Territory / Distribution category: GB, POM-V

Authorisation holder: Boehringer Ingelheim Animal Health UK Limited

Link to SPC Cats and Guinea Pigs

Link to SPC Dogs

Active substance: Atinvicitinib

Territory / Distribution category: NI, POM-V

Authorisation holder: Intervet International BV

SPCs available from EU Union Product Database

Active substance: Omeprazole

Territory / Distribution category: NI  POM-V

Authorisation holder: TriviumVet DAC

SPC available from EU Union Product Database

Active substance: Imidacloprid, Flumethrin

Territory / Distribution category: NI  NFA-VPS

Authorisation holder: VIRBAC

Link to SPC 1.25g + 0.56g Cats

Link to SPC 1.25g + 0.56g Dogs

Link to SPC 4.50g +0.56g Dogs over 8kg

Active substance: Ilunocitinib

Territory / Distribution category: NI  POM-V

Authorisation holder: Elanco GmbH

SPCs available from EU Union Product Database

Active substance: Bovine parainfluenza virus 3, Bovine respiratory syncytial virus, 

E2 recombinant protein, Infectious bovine rhinotracheitis virus

Territory / Distribution category: NI POM-V

Authorisation holder: Laboratorios Hipra SA

Change Category: Target species use; adverse reactions

Summary of change:  

Section 4.9: Clarification of the temperature of use (15 °C – 25 °C) to ensure the correct handling of the veterinary medicinal product.  

Section 3.6: Addition with a frequency of uncommon adverse events related to a temporary mild reduction in milk production, feed intake and activity.

SPC available from EU Union Product Database

Active substance: Porcine respiratory and reproductive syndrome virus

Territory / Distribution category: NI POM-V

Authorisation holder: Laboratorios Hipra SA

Change Category: Target Species Use

Summary of change:  

Sections 3.2 and 3.9: Update to reduce the minimum age of vaccination of pigs from 4 weeks to 3 weeks.  

Link to SPC

Active substance: Butafosfan, Cyanocobalamin

Territory / Distribution catgory: NI POM-V

Authorisation holder: Veyx-Pharma GmbH

Change category: Target Species Use

Summary of change:  

Section 3.1: Removal of cats as a target species.

Section 3.2: updated indications:

All target species:

- Supportive treatment and prevention of hypophosphatemia and/or cyanocobalamin (vitamin B12) deficiency.

Cattle:

- Supportive treatment to restore rumination following surgical treatment of displaced abomasum associated with secondary ketosis. 

- Complementary treatment of parturient paresis in addition to Ca/Mg therapy. 

- Prevention of ketosis development, if administered before calving. 

Horses:

- Adjunctive therapy in horses suffering from muscular exhaustion.

Link to SPC

Active substance: Fluralaner

Territory / Distribution category: NI POM-V

Authorisation holder: Intervet International B.V.

Change Category: Adverse Reactions

Summary of change:  

Section 3.6: Addition of ataxia and pruritus with a frequency of very rare (<1 animal/10,000 animals treated, including isolated reports). 

SPCs available from EU Union Product Database

Active substance: Fluralaner

Territory / Distribution category: NI POM-V

Authorisation holder: Intervet International B.V

Change Category: Adverse Reactions

Summary of change:  

Section 3.6: Addition of diarrhoea with a frequency of common (1 to 10 animals / 100 animals treated), and pruritus with a frequency of very rare (<1 animal/10,000 animals treated, including isolated reports). 

SPCs available from EU Union Product Database

Active substance: Febantel, Praziquantel, 

Pyrantel Embonate

Territory / Distribution category: NI POM-V

Authorisation holder: Laboratorios Hipra SA

Change Category: Adverse Reactions

Summary of change:  

Section 3.6: Addition of lethargy, anorexia, and hyperactivity with a frequency of very rare (<1 animal/10,000 animals treated, including isolated reports).

Link to SPC

Active substance: Canine adenovirus, Canine distemper virus, Canine parainfluenza virus, Canine parvovirus

Territory / Distribution category: UK POM-V

Authorisation holder: Boehringer Ingelheim Animal Health UK Limited

Change Category: Interactions and Overdose

Summary of change:  

Section 4.8: To add the compatibility claim for Eurican DHPPi with Eurican L4.

Link to SPC

Active substance: Eprinomectin, Esafoxolaner, Praziquantel

Territory / Distribution category: NI POM-V

Authorisation holder: Boehringer Ingelheim Vetmedica GmbH

Change Category: Target Species Use

Summary of change:  

Section 3.2: Addition of a new indication: for the treatment of infections with eye worms (Thelazia callipaeda).

Modification of an indication for immediate tick killing activity against Ixodes hexagonus

Corresponding changes have been made to sections 3.4, 3.9, and 4.3 of the SPCs.

SPCs available from EU Union Product Database

Active substance: Afoxolaner, Milbemycin Oxime (A3 and A4)

Territory / Distribution category: NI POM-V

Authorisation holder: Boehringer Ingelheim Vetmedica GmbH

Change Category: Target Species Use

Summary of change:  

Section 3.2: Addition of two new indications:

For reduction of the risk of infection with Dipylidium caninum via transmission by Ctenocephalides felis for 30 days.

For reduction of the risk of infection with Babesia canis canis via transmission by Dermacentor reticulatus for 28 days.

The effects are indirect due to the activity of the veterinary medicinal product against the vectors.

Corresponding changes have been made to sections 3.4, 3.9, and 4.3 of the SPCs.

SPC available from EU Union Product Database

Active substance: Leptospira australis, Leptospira canicola, Leptospira grippotyphosa, Leptospira icterohaemorrhagiae

Territory / Distribution category: NI POM-V

Authorisation holder: Intervet International B.V.

Change Category: Target Species Use; Interactions and Overdose

Summary of change:  

Section 3.2: Addition of a new therapeutic indication for 2 new Leptospira serovars, and existing Leptospira serovars.

Section 3.8: Addition of associated non-mixed use with Nobivac Rabies vaccine.

SPC available from EU Union Product Database

Active substance: Leptospira interrogans serogroup Australis, Leptospira interrogans serogroup Canicola, Leptospira interrogans serogroup Icterohaemorrhagiae, Leptospira kirschneri serogroup Grippotyphosa

Territory / Distribution category: NI POM-V

Authorisation holder: Intervet International B.V.

Change Category: Target Species Use; Interactions and Overdose

Summary of change:  

Section 3.2: Addition of a new therapeutic indication for 2 new Leptospira serovars, and existing Leptospira serovars.

Section 3.8: Addition of associated non-mixed use with Nobivac Rabies vaccine.

SPC available from EU Union Product Database

Active substance: Febantel, Praziquantel, Pyrantel

Territory / Distribution category: GB NFA-VPS

Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd

Change Category: Adverse Reactions

Summary of change:  

Section 3.6: Addition of lethargy, anorexia, and hyperactivity with a frequency of very rare (<1 animal/10,000 animals treated, including isolated reports).

Link to SPC

Active substance: Febantel, Praziquantel, Pyrantel Embonate

Territory / Distribution category: GB NFA-VPS

Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd

Change Category:  Adverse Reactions

Summary of change:  

Section 3.6: Addition of lethargy, anorexia, and hyperactivity with a frequency of very rare (<1 animal/10,000 animals treated, including isolated reports).

Link to SPC

Active substance: Flumethrin, Imidacloprid

Territory / Distribution category: UK NFA-VPS

Authorisation holder: Elanco Europe Ltd

Change Category: Adverse Reactions

Summary of change:  

Section 3.6: Addition of application site reaction (haemorrhage and scratching), behavioural disorder (vocalisation) and lethargy with a frequency of rare (1 to 10 animals / 10000 animals treated).

Link to SPC Cats

Link to SPC small dogs

Link to SPC large dogs

Active substance: Moxidectin, Pyrantel, Sarolaner

Territory / Distribution category: GB POM-V

Authorisation holder: Zoetis UK Limited

Change Category: Target Species Use

Summary of change:  

Section 3.2: Added for the treatment of Angiostrongylus vasorum.

Section 3.9: Treatment of angiostrongylosis (caused by Angiostrongylus vasorum):

A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.  A further assessment should then be carried out following the second treatment. Continued monitoring should be performed as appropriate for each case. 

Link to SPC 1.25-2.5kg

Link to SPC >2.5-5kg

Link to SPC >5-10kg

Link to SPC >10-20kg

Link to SPC >20-40kg

Link to SPC >40-60kg

Active substance: Butafosfan

Cyanocobalamin

Territory / Distribution category: NI POM-V

Authorisation holder: Veyx-Pharma GmbH

Change Category: Target Species Use

Summary of change:  

Section 3.1: Removal of cats as a target species.

Section 3.2: updated indications for all target species: Supportive treatment and prevention of hypophosphatemia and/or cyanocobalamin (vitamin B12) deficiency.

Link to SPC